Reactive Stepping Training in Individuals With Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT02960178|
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Behavioral: Perturbation-based training Behavioral: Conventional walking training||Not Applicable|
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The research aim is to determine if perturbation-based training (PBT) leads to greater improvements in balance reactions, scores on clinical scales, and fall rates compared with conventional gait training. The investigators hypothesize that individuals with iSCI who participate in PBT will show significantly greater gains in: 1) the ability to take a reactive step during the lean-and-release test, as evidenced by a reduction in both the time taken to initiate the reaction, and the number of steps taken to regain balance; and 2) clinical measures of gait, balance, and balance self-efficacy. The investigators also hypothesize that individuals who participate in PBT will experience fewer falls in the 6 months following training than the conventional training group.
All 24 participants with iSCI will complete 2 baseline assessments spaced 2 weeks apart. The participants will then be randomized into perturbation-based training and conventional gait training (12 participants/group) using a matched pairs design. Participants will be matched based on AIS level (C or D) and age (<60 years or >60 years). For both programs, the dosage will be 3 sessions/week for 8 weeks, with each session lasting 1 hour. After training, follow-up assessments, including the lean-and-release test and clinical measures, will be completed at 3 and 6 months post-training. PBT and conventional gait training will be delivered by a graduate student with a background in Physical Therapy or Kinesiology and supervised by a licensed physical therapist. PBT will consist of repetitive practice of reactive stepping for 1 hour. Participants will experience 60 perturbations per session during standing and walking activities, such as standing on a compliant surface or with eyes closed, stepping on targets on the ground, or stepping sideways. To create a perturbation, the researcher will apply unexpected pushes or pulls to a safety harness around the participant's trunk. The perturbation will be sufficient in magnitude to elicit a stepping response from the participant. Conventional training will consist of treadmill (0.5 hr) and over-ground (0.5 hr) gait training. On the treadmill, participants will walk as fast and as long as possible. Body weight-support may be used, if needed. During over-ground walking, participants will practice similar activities to the PBT group, but no perturbations will be applied. After the training period, participants will be followed for 6 months to track the occurrence and consequences of falls. If a participant experiences a fall, he/she will be asked to complete a short survey (online or on paper) within 24 hours of falling. A researcher will maintain monthly contact with participants to ensure falls are documented. Assessments will be performed twice during the baseline period, and after 4 and 8 weeks of training, and 3 and 6 months post-training for those participating in the RCT. The lean-and-release test will be administered by the research team due to the technical expertise required. All other measures will be administered by licensed PTs who are blind to study purpose and training allocation. The lean-and-release test will quantify the ability to take reactive steps. Participants will stand on a force plate and lean forward with 5-10% of their body weight supported by a horizontal cable. The cable is released at an unpredictable time, and participants must take a reactive step forward onto a second force plate. Ground reaction forces and surface electromyography of the legs (rectus femoris, vastus lateralis, biceps femoris, soleus, medial gastrocnemius, and tibialis anterior) will be recorded. The lean-and-release test has good test-retest reliability in older adults. The Mini-Balance Evaluation System's Test assesses four balance control systems, including postural responses to perturbations. This scale has been used in SCI, and has shown good validity and reliability in stroke and Parkinson's disease. The Activities-specific Balance Confidence Scale is a questionnaire on balance self-efficacy. Participants rate their confidence in their ability to maintain balance while performing 16 functional tasks. It has been used in individuals with SCI and has good psychometric properties in stroke. Spatio-temporal gait parameters, such as step width and double support time, will be collected with the Zeno Walkway (ProtoKinetics).
All electromyography (EMG), force plate and motion capture data will be sampled at 1 kHz. The EMG signals will amplified and bandpass filtered between 20-500Hz. EMG and force plate signals will be used to determine the timing of the reactive step, elicited by the lean-and-release test. The magnitude of activity in each muscle during the reactive step will evaluated using the root mean square of each muscle's EMG. The Shapiro-Wilk test will be used to test the assumption of normality. To compare the outcomes of the 2 training programs, a one-way repeated measures ANOVA or Friedman's Test will be used. The alpha level will be set at 0.05.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Assessment and Training of Reactive Stepping in Individuals With Spinal Cord Injury|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Perturbation-based training
Participants will practice standing and walking activities while secured in an overhead harness attached to an overhead track. While practicing these tasks, the trainer will apply pushes and pulls to the harness at unexpected times, causing a reactive step to be practiced.
Behavioral: Perturbation-based training
Over-ground practice of stepping and balance tasks in standing with perturbations applied by the trainer (pushes and pulls to the safety harness). One hour in duration with 60 perturbations targeted per hour.
Active Comparator: Conventional walking training
Participants will practice standing and walking activities while secured in an overhead harness attached to an overhead track. No external perturbations will be applied.
Behavioral: Conventional walking training
Over-ground practice of stepping and balance tasks in standing. One hour in duration.
- Change in reactive stepping ability (Lean and Release Test) [ Time Frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training ]Inness EL, Mansfield A, Biasin L, et al. Clinical implementation of a reactive balance control assessment in a sub-acute stroke patient population using a 'lean-and-release' methodology. Gait & Posture 2015; 41: 529-34.
- Change in the Mini-BESTest score [ Time Frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training ]Clinical measure of balance
- Change in the Activities-specific Balance Confidence Scale score [ Time Frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training ]Questionnaire
- Change in the Community Balance & Mobility Scale [ Time Frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training ]Clinical measure of balance
- Change in spatiotemporal measures of gait [ Time Frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training ]Zeno walkway
- Change in the Falls Efficacy Scale - International score [ Time Frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training ]Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960178
|Contact: Kristin Musselman, PhD||416-597-3422 ext 6190||Kristin.Musselman@uhn.ca|
|Lyndhurst Centre, Toronto Rehabilitation Institute-UHN||Recruiting|
|Toronto, Ontario, Canada, M4G 3V9|
|Contact: Kristin Musselman, PhD 416-597-3422 ext 6190 Kristin.Musselman@uhn.ca|